Kornimate/medical-research-clean huggingface dataset:
smartphone behavior and epilepsy management

Conditions: Epilepsy

Summary: in this prospective cohort study smartphone behavior surrounding epileptic seizures will be quantified, using a smartphone app, in order to optimize epilepsy evaluation and treatment

rationale: the unpredictability of seizures and the unclear behavioral outcomes are major concerns for people with epilepsy and may surface as increased anxiety about independence. this unpredictability is also a true obstacle in capturing and studying seizure-related neurobehavioral alterations themselves. also, seizures often impact consciousness and thus may go unnoticed. as a result, subjective seizure diaries are unreliable. continuous smartphone-based monitoring of behavioral output is a fast-emerging topic and proven fruitful in monitoring other neurological disease states. in the field of epilepsy, these tools are yet to be introduced. objective: the investigators hypothesize that quantifying smartphone behavior will help obtain a detailed and objective behavioral map of seizures that can complement existing subjective seizure diaries and thereby improve the way epilepsy treatments are evaluated in daily practice. study design: a multicentre observational prospective cohort study with at least 3 months follow-up. study population: 100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month. main study parameters/endpoints: change in touchscreen interactions (tapping speed, texting speed, apps used, location, sleep-wake cycles) surrounding reported epileptic seizures.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * clinical diagnosis of refractory focal epilepsy meeting ilae criteria16, 17 * supported by at least one of the following; (1) interictal eeg with epileptiform discharges, (2) epileptogenic lesion on mri corresponding to the presumed seizure onset zone, or (3) seizure recorded during a video-eeg * have a seizure frequency of ≥ 1 per month * only one seizure type, or in case of multiple seizure types only seizures that correspond to one probable onset zone (e.g. focal and focal to bilateral tonic-clonic seizures) * have daytime seizures (exclusively or both daytime and night-time seizures) * mentally competent and with no learning disabilities * able to keep a seizure diary including time and date (as judged by the treating physician) * have an android-operating smartphone * use their phone with at least 5 distinct smartphone apps at a minimum of 5 days a week exclusion criteria: * not fulfilling the above mentioned inclusion criteria
efficacy of adductor canal block for anterior cruciate ligament surgery

Conditions: Anterior Cruciate Ligament Injuries

Summary: the goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery

patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent. before surgery, patients will receive an adductor canal bock with levobupivacaine (intervention group) or 0.9% saline (control group). following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.

Eligibility criteria:
inclusion criteria: * age 18 or older * undergoing anterior cruciate ligament surgery under general anesthesia * asa i-iii exclusion criteria: * contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics, * neuromuscular disorders

Keywords: adductor canal block
children's taste study to increase vegetable intake in preschoolers

Conditions: Pediatric Obesity

Summary: studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented. this strategy has been used to increase vegetable intake in adults and during snacktime in children. increasing vegetable consumption in children is important because higher vegetable intake has been associated with reduced risk of disease and because vegetables can help prevent weight gain by lowering the energy density of a meal. the purpose of this study was to investigate the effects of using herb and spice blends to create flavor variety in carrots as a model vegetable in a laboratory test meal. we predict that children will consume more vegetables and that the energy density of the meal will be lower when a variety of seasoned carrots are presented in comparison to a single flavor. a secondary goal of the study was to determine other influences that may predict children's liking and intake of seasoned vegetables, such as previous exposure, infant feeding practices, and genetic bitter sensitivity.


Eligibility criteria:
inclusion criteria: * acceptance of test meal foods * generally healthy exclusion criteria: * food allergies * medications (prescription or otc) that can affect taste, smell or appetite * medical conditions

Keywords: eating behaviors preschool vegetable intake
cdc-501 therapy in relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of the study is to select the dose regimen of cdc-501 that provides the most promising evidence of efficacy.


Eligibility criteria:
* subject must be diagnosed with multiple myeloma (with measurable m-protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment. * subject must understand and voluntarily sign an informed consent document. * subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline * ecog (zubrod) performance status of 0 to 2. * subject must be able to adhere to the study visit schedule and other protocol requirements. * women of childbearing potential (wcbp ) must have a negative serum or urine pregnancy test within 7 days of baseline. in addition, sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Keywords: revimid cc5013
efficacy and safety of lanthanum carbonate and sevelamer hydrochloride in patients receiving haemodialysis for end stage renal disease

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to assess phosphate reduction and control in patients with end stage renal disease treated with either lanthanum carbonate or sevelamer hydrochloride


Eligibility criteria:
inclusion criteria: * patients receiving haemodialysis for esrd * patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months exclusion criteria: * pregnant or lactating women * patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma * patients who are hiv+ * patients with any significant bowel obstruction, active inflammatory bowel disease, gi motility disorders, or a history of major gi surgery within the last 6 months
effect of antenatal education on fear of childbirth

Conditions: Fear of Childbirth; Stress

Summary: the aim of this study was to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, maternal self-efficacy, and mode of delivery in primiparous pregnant women

there is still a lack of evidence regarding the effects of antenatal education on birth fear, maternal self-efficacy, anxiety, stress, depression, and mode of delivery. therefore, this study aimed to investigate the effects of antenatal education on birth fear, anxiety, stress, depression, maternal self-efficacy, and mode of delivery

Eligibility criteria:
inclusion criteria: * literate * childbirth at fullterm (born at 38-42 weeks) * nulliparous women * women between the ages of 18-35 * singleton pregnancy in 20 and 36 weeks of gestation * having a healthy newborn * no participation in another prenatal program * absence of any psychiatric illness or comorbidities * no use medications for a diagnosed mental disorder * baby with normal birth weight and apgar score of 8 and above * women who have not developed postpartum complications * women without complicated/high-risk pregnancies, who do not experience a perinatal death or stillbirth * speaks and understands turkish * women with a total fear of childbirth score w-deq-a ≥60 will be included. * women who give birth through vaginal route exclusion criteria: • women who do not meet the sample selection criteria

Keywords: antenatal education fear of childbirth depression, anxiety stress maternal self-efficacy mode of delivery
safety and effectiveness of biotraceio 360 for planning, monitoring and assessment of liver tissue ablation procedures

Conditions: Hepatocellular Carcinoma; Metastatic Liver Cancer

Summary: pilot study planned to demonstrate the safety and effectiveness of the use of biotraceio 360 for planning, monitoring and assessment of liver tissue ablation procedures multi-center (up to 5 investigational sites) prospective single-arm clinical investigation. sample size - 30 subjects.


Eligibility criteria:
inclusion criteria: * scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (hcc) or metastatic liver tumor(s) microwave (mw) energy. * patient must have at least one prior ct or cect scan (up to 6 months before enrollment). * tumor must be visualized on at least one diagnostic imaging modality (mri or contrast-enhanced ct). * single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones. * distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones. * at least 21 years of age. * able and willing to give informed consent. additional inclusion criteria for subgroup: * single ablation, using a single ablation needle, per tumor. exclusion criteria: * planned ablation includes adjunctive means other than mw energy (e.g., ethanol, hepatic artery embolization, etc.). * planned ablation includes the use of more than two ablation needles, per tumor * ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure. * pregnant or breastfeeding. * patient judged unsuitable for study participation by the physician for any other reason. * currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period. * unable or unwilling to give informed consent. additional exclusion criteria for subgroup: * liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion. * planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.
theranostic tool during erlotinib treatment in non-small cell lung cancer patient

Conditions: Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent; No EGFR Activating Mutation

Summary: in france, lung cancer is the leading cause of death induced by cancer. therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (nsclc) with tyrosine kinase receptor inhibitors blocking the epidermal growth factor receptor (egfr), as erlotinib. this drug usually does not induce rapid shrinking of nsclc tumour explaining why recist criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment. among patients with unresectable nsclc, 3'-deoxy-3'-18f-fluoro-l-thymidine (18f-flt) and 18f-2-18f-fluoro-2-deoxy-d-glucose (18f- fdg) positron emission tomography (pet) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line. to date, none medico-economic study has been conducted to determine if this strategy will be cost-effective. the purpose of this study is to confirm that an early metabolic imaging with 18 f-flt and 18ffdg pet could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new recist 1.1, that is typically done at week 8 of erlotinib treatment. a health economics ancillary study will be achieved. indeed, recent therapeutic improvements, in particular targeted therapies in nsclc, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. according to studies, the mean cost of the treatments of nsclc has been increased by a factor 3 during the 10 last years. more efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology. the potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.


Eligibility criteria:
inclusion criteria: * age over superior to 18 * nsclc proved by a histological biopsy * egfr mutation status known with no activating egfr mutation * indication of erlotinib therapy after at least one previous therapy * patients who have signed an informed consent to participate in this study * life expectancy exceeding 12 weeks * who activity score between 0 and 2. exclusion criteria: * contraindication for the initiation of erlotinib * refusal to sign the consent * progressive inflammatory disease * infection with the hiv virus * other malignant disease * life expectancy less than 12 weeks * major adults protected by french law
prednisone in chronic rhinosinusitis without nasal polyps

Conditions: Sinusitis; Chronic Rhinosinusitis

Summary: the purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.

general objective: 1. compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (crssnp) through application of snot 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using lund-kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days. specific objectives: 1. compare decreased in snot-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo. 2. compare decreased in nasal endoscopy findings, through application of lund-kennedy score, after treatment with prednisone or placebo. 3. compare improvements in smell after treatment with prednisone or placebo. 4. determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo. 5. determine whether there is a difference in the snot 22 questionnaire score, visual analogue scale of symptoms, score of smell and lund-kennedy score between crssnp patients and eosinophilia, and crssnp patients with normal eosinophils, receiving prednisone or placebo . 6. determine if there is a difference in the snot 22 questionnaire score, visual analogue scale of symptoms, score of smell and lund-kennedy score between crssnp patients with elevated total immunoglobulin e and crssnp patients with normal total immunoglobulin e, receiving treatment with prednisone or placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of crssnp as recommended european position paper on rhinosinusitis and nasal polyps 2012 exclusion criteria: * treatment with oral corticosteroids or topical corticosteroids the last 4 weeks. * previous surgical treatment for crssnp * history of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer. * pregnancy. * history of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction. * hypersensitivity to prednisone

Keywords: chronic rhinosinusitis without nasal polyps prednisone
evaluation of the effect of central sensitivity on pain and functional status after total knee joint replacement surgery

Conditions: Central Sensitisation; Postoperative Pain; Arthritis

Summary: the study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery. the aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis. when the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. in this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.


Eligibility criteria:
inclusion criteria: * diagnosis of primary knee osteoarthritis * planning for total joint replacement surgery for the knee * being between the ages of 60-75 exclusion criteria: * having secondary knee osteoarthritis * planning for knee total joint prosthesis revision * having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease) * having neuromuscular disease * having a body mass index over 40
can the hypertrophy of contralateral testis predict the absence of the non-palpable testis in the boys aged from 6months to 18months of age ?

Conditions: Focus of Study

Summary: the aim of this study is to verify whether the hypertrophy of contralateral testis may predict the absence of the non-palpable testis in the boys younger than 24months of age. according to the previous studies of other countries, the large size of the contralateral testis of the nonpalpable testis has positive correlation woth the weak viability of the affected testis. we are going to evaluate this hypothesis with prospective study. 3 groups are going to be enrolled into this study ; non-palpable testis group(group1), palpable but not normally descended testis group(group2) and control group(group3). the size of testis will be measured with ultrasound and the length, width and the height will be measured before surgery at outpatient department. for the group 1 \& 2, the viability of the affected testis will be evaluated and compared after surgery. in addition the comparison with normal control group is also going th be conducted.


Eligibility criteria:
inclusion criteria: 1. neonates or infants who visited the out-patient clinic with nonpalpable or undescended testis.(group 1, 2) aged from 6months to 18months 2. neonates or infants aged from 6months to 18months with normal testis (volunteers, group3) exclusion criteria: 1. previous history of hormonal therapy. 2. chromosomal abnormality 3. previous history of abdomen or inguinal area surgery 4. children diagnosed with epididymitis or orchitis 5. twin baby 6. infants with premature (\<37 weeks) birth history

Keywords: cryptorchidism, undescended testis, hypertrophy of contralateral testis
short-term efficacy of triamcinolone acetonide (aristocort® c) in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (aristocort® c) in subjects with atopic dermatitis.

this study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (aristocort® c) on pruritus, skin biomarkers and skin parameters in subject with atopic dermatitis. approximately 20 subjects with atopic dermatitis will receive twice-daily topical application of triamcinolone acetonide (aristocort® c) or vehicle in two different randomized areas for 3 days.

Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 years of age or older at the time of consent. 2. subject has clinically confirmed diagnosis of active ad, according to hanifin and rajka criteria. 3. subject has at least a 6-month history of ad and had no significant flares in ad for at least 4 weeks before screening. 4. subject has 2 applications areas (10 x 10 cm) with a lesional surface of at least 6 x 6 cm, preferably located on 2 distinct anatomical areas at day 1. exclusion criteria: 1. subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. 2. subject has clinically infected ad. 3. subject has a fitzpatrick's skin phototype ≥5. 4. subject has a history of skin disease or presence of skin condition, other than ad, that would interfere with the study assessments in the opinion of the investigator. 5. subject is known to have immune deficiency or is immunocompromised. 6. subject has a history of cancer or lymphoproliferative disease within 5 years prior to day 1. 7. subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. 8. subject has a known history of chronic infectious disease. 9. subject has a known or suspected allergy to triamcinolone acetonide (aristocort® c) or any component of the investigational product.

Keywords: atopic dermatitis aristocort triamcinolone acetonide
a pilot study of lactofiltrum to treat atopic dermatitis in adults

Conditions: Atopic Dermatitis

Summary: the purpose is to study efficacy of lactofiltrum in adult patients with atopic dermatitis. lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. additionally, lactulose stimulates bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.


Eligibility criteria:
inclusion criteria: * patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the uk refinement of the hanifin-rajka diagnostic criteria; * scorad index more than 25. exclusion criteria: * pregnancy and breast-feeding; * severe diseases; * concomitant infection diseases (including parasitic ones); * diffusive connective-tissue (autoimmune) diseases; * renal and hepatic failure; * systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion into the study; * concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis; * professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation; * psychoses; * application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeks before inclusion or during participation in the study; * participation in other clinical study 1 month before inclusion or during participation in the proposed study.

Keywords: lactofiltrum atopic dermatitis itching dermatological index of life quality scorad behavioral rating scores